Evidence map›Paper›PMID 42774586›Full record

ArticleJTO clinical and research reports2026

Perioperative Pembrolizumab in Japanese Participants With Early-Stage NSCLC: Subgroup Analysis From KEYNOTE-671.

Masahiro Tsuboi, Hisashi Saji, Morihito Okada, Norihiko Ikeda, Kazuya Takamochi, Kenji Sugio, Yoshitsugu Horio, Fumihiro Tanaka, Wataru Nishio, Satoshi Muto and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in JTO clinical and research reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03425643 (A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03425643 phase3active not recruitingnot on this map

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2018 to 2026Enrolled797ConditionsNon-small Cell Lung CancerArmsPembrolizumab, Placebo, Cisplatin, Gemcitabine, Pemetrexed
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Masahiro TsuboiNational Cancer Center Hospital East, Chiba, Japan.
Hisashi SajiSt. Marianna University School of Medicine Hospital, Kanagawa, Japan.
Morihito OkadaHiroshima University Hospital, Hiroshima, Japan.
Norihiko IkedaTokyo Medical University Hospital, Tokyo, Japan.
Kazuya TakamochiJuntendo University School of Medicine, Tokyo, Japan.
Kenji SugioOita University Hospital, Oita, Japan.
Yoshitsugu HorioAichi Cancer Center Hospital, Nagoya, Japan.
Fumihiro TanakaHP of the Univ. of Occupational and Environmental Health, Fukuoka, Japan.
Wataru NishioHyogo Cancer Center, Hyogo, Japan.
Satoshi MutoFukushima Medical University Hospital, Fukushima, Japan.
Hidehito HorinouchiNational Cancer Center Hospital, Tokyo, Japan.
Heather WakeleeStanford University School of Medicine/Stanford Cancer Institute, Stanford, California.
Shirong HanMSD K.K., Tokyo, Japan.
Tomoko MoriMSD K.K., Tokyo, Japan.
Steven M KellerMerck & Co., Inc., Rahway, New Jersey.
Terufumi KatoKanagawa Cancer Center, Yokohama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The global KEYNOTE-671 (clinicaltrials.gov: NCT03425643) study demonstrated significantly improved survival with perioperative pembrolizumab plus neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in early-stage non-small-cell lung cancer (NSCLC). We present findings from Japanese participants from KEYNOTE-671. Methods: Eligible participants (≥18 y) with previously untreated stage II, IIIA, or IIIB (N2) NSCLC were randomized 1:1 to neoadjuvant pembrolizumab 200 mg or placebo plus cisplatin-based chemotherapy every 3 weeks for up to 4 cycles followed by surgery and adjuvant pembrolizumab or placebo for up to 13 cycles (approximately 9 mo). Primary endpoints were event-free survival (EFS) and overall survival (OS). Results: Among 82 participants enrolled in Japan, 39 were randomized to pembrolizumab and 43 to placebo. Median time from randomization to database cutoff (August 19, 2024) was 52.7 (range, 32.7-74.9) months. The 48-month EFS rates (95% confidence intervals [CIs]) were 60.3% (42.8%-74.0%) and 39.2% (24.8%-53.4%), respectively, and the EFS hazard ratio was 0.54 (95% CI: 0.29-1.02). For OS, 48-month rates (95% CIs) were 79.5% (63.1%-89.2%) and 68.9% (52.4%-80.7%), and the OS hazard ratio was 0.76 (95% CI: 0.33-1.78). Grade 3 or higher treatment-related adverse events occurred in 23 participants (59%) treated with pembrolizumab and 20 participants (47%) with placebo; there were no deaths due to treatment-related adverse events. Conclusions: Perioperative pembrolizumab plus neoadjuvant chemotherapy improved efficacy versus neoadjuvant chemotherapy alone and had manageable safety in Japanese participants enrolled in KEYNOTE-671, supporting the use of perioperative pembrolizumab in Japanese patients with early-stage NSCLC.

Indexed as

ImmunotherapyJapanNon–small-cell lung cancerPembrolizumabPerioperative medicine

Identifiers

PMID42774586
PMCPMC13595008

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Registered trials

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